DELAWARE REGISTER OF REGULATIONS The Delaware Register of Regulations is an official State publication established by authority of 69 Del. Laws, c. 107 and is published on the first of each month throughout the year. The Delaware Register will publish any regulations that are proposed to be adopted, amended or repealed and any emergency regulations promulgated. The Register will also publish some or all of the following information: •Governor’s Executive Orders •Governor’s Appointments •Agency Hearing and Meeting Notices •Other documents considered to be in the public interest. CITATION TO THE DELAWARE REGISTER The Delaware Register of Regulations is cited by volume, issue, page number and date. An example would be: 9 DE Reg. 1036-1040 (01/01/06) Refers to Volume 9, pages 1036-1040 of the Delaware Register issued on January 1, 2006. SUBSCRIPTION INFORMATION The cost of a yearly subscription (12 issues) for the Delaware Register of Regulations is $135.00. Single copies are available at a cost of $12.00 per issue, including postage. For more information contact the Division of Research at 302-744-4114 or 1-800-282-8545 in Delaware. CITIZEN PARTICIPATION IN THE REGULATORY PROCESS Delaware citizens and other interested parties may participate in the process by which administrative regulations are adopted, amended or repealed, and may initiate the process by which the validity and applicability of regulations is determined. Under 29 Del.C. §10115 whenever an agency proposes to formulate, adopt, amend or repeal a regulation, it shall file notice and full text of such proposals, together with copies of the existing regulation being adopted, amended or repealed, with the Registrar for publication in the Register of Regulations pursuant to §1134 of this title. The notice shall describe the nature of the proceedings including a brief synopsis of the subject, substance, issues, possible terms of the agency action, a reference to the legal authority of the agency to act, and reference to any other regulations that may be impacted or affected by the proposal, and shall state the manner in which persons may present their views; if in writing, of the place to which and the final date by which such views may be submitted; or if at a public hearing, the date, time and place of the hearing. If a public hearing is to be held, such public hearing shall not be scheduled less than 20 days following publication of notice of the proposal in the Register of Regulations. If a public hearing will be held on the proposal, notice of the time, date, place and a summary of the nature of the proposal shall also be published in at least 2 Delaware newspapers of general circulation. The notice shall also be mailed to all persons who have made timely written requests of the agency for advance notice of its regulation-making proceedings. The opportunity for public comment shall be held open for a minimum of 30 days after the proposal is published in the Register of Regulations. At the conclusion of all hearings and after receipt, within the time allowed, of all written materials, upon all the testimonial and written evidence and information submitted, together with summaries of the evidence and information by subordinates, the agency shall determine whether a regulation should be adopted, amended or repealed and shall issue its conclusion in an order which shall include: (1) A brief summary of the evidence and information submitted; (2) A brief summary of its findings of fact with respect to the evidence and information, except where a rule of procedure is being adopted or amended; (3) A decision to adopt, amend or repeal a regulation or to take no action and the decision shall be supported by its findings on the evidence and information received; (4) The exact text and citation of such regulation adopted, amended or repealed; (5) The effective date of the order; (6) Any other findings or conclusions required by the law under which the agency has authority to act; and (7) The signature of at least a quorum of the agency members. The effective date of an order which adopts, amends or repeals a regulation shall be not less than 10 days from the date the order adopting, amending or repealing a regulation has been published in its final form in the Register of Regulations, unless such adoption, amendment or repeal qualifies as an emergency under §10119. Any person aggrieved by and claiming the unlawfulness of any regulation may bring an action in the Court for declaratory relief. No action of an agency with respect to the making or consideration of a proposed adoption, amendment or repeal of a regulation shall be subject to review until final agency action on the proposal has been taken. When any regulation is the subject of an enforcement action in the Court, the lawfulness of such regulation may be reviewed by the Court as a defense in the action. Except as provided in the preceding section, no judicial review of a regulation is available unless a complaint therefor is filed in the Court within 30 days of the day the agency order with respect to the regulation was published in the Register of Regulations. CLOSING DATES AND ISSUE DATES FOR THE DELAWARE REGISTER OF REGULATIONS ISSUE DATECLOSING DATECLOSING TIME March 1February 154:30 p.m. April 1March 154:30 p.m. May 1April 164:30 p.m. June 1May 154:30 p.m. July 1June 154:30 p.m. DIVISION OF RESEARCH STAFF Deborah A. Porter, Interim Supervisor; Kathleen Morris, Administrative Specialist I; Georgia Roman, Unit Operations Support Specialist; Jeffrey W. Hague, Registrar of Regulations; Steve Engebretsen, Assistant Registrar; Victoria Schultes, Administrative Specialist II; Lady Johnson, Administrative Specialist I; Rochelle Yerkes, Administrative Specialist II; Ruth Ann Melson, Legislative Librarian; Debbie Puzzo, Research Analyst; Judi Abbott, Administrative Specialist I; Alice W. Stark, Senior Legislative Attorney; Deborah J. Messina, Print Shop Supervisor; Don Sellers, Printer; Teresa Porter, Printer. Cumulative Tables......................................................................................................................................... 1173 EMERGENCY DEPARTMENT OF INSURANCE 1301 Arbitration of Health Insurance Claims and Internal Review Process of Medical Insurance Carriers 1180 1403 Health Maintenance Organizations [Formerly Regulation 58] ........................................................ 1190 PROPOSED DEPARTMENT OF EDUCATION Office of the Secretary 502 Alignment of Local School District Curricula to the State Content Standards ........................... 1202 540 Driver Education ........................................................................................................................ 1205 Professional Standards Board 1501 Knowledge, Skills and Responsibility Based Salary Supplements for Educators .................... 1208 1516 Standard Certificate ................................................................................................................. 1213 DEPARTMENT OF HEALTH AND SOCIAL SERVICES Division of Medicaid and Medical Assistance DSSM 20320 Ownership of Real Property by Institutionalized Individuals, and 20330.3 Promissory Notes, Loans and Property Agreements .................................................................................... 1216 DSSM 20330.7 US Savings Bonds .................................................................................................. 1219 DSSM 20910.1 Institutionalized Spouse .......................................................................................... 1220 Division of Public Health 4104 Conrad State 30/J-1 Visa Waiver Program .............................................................................. 1221 DEPARTMENT OF INSURANCE 608 Automobile Insurance Coverage .................................................................................................... 1232 1301 Arbitration of Health Insurance Claims and Internal Review Process of Medical Insurance Carriers 1233 1403 Health Maintenance Organizations [Formerly Regulation 58] ........................................................ 1249 DEPARTMENT OF NATURAL RESOURCES AND ENVIRONMENTAL CONTROL Division of Air and Waste Management 1142 Specific Emission Control Requirements, Section 2.0 Control of NOx Emissions from Industrial Boilers and Process Heaters at Petroleum Refineries ................................................ 1280 Division of Fish and Wildlife 3581 Spiny Dogfish; Closure of Fishery (Formerly Tidal Finfish Reg. 27) ........................................ 1285 DEPARTMENT OF STATE Division of Professional Regulation 2000 Delaware Board of Occupational Therapy ............................................................................... 1286 2700 Board of Professional Land Surveyors ................................................................................... 1290 3500 Board of Examiners of Psychologists, Sections 5.0, 10.0 and 13.0 ........................................ 1295 FINAL DEPARTMENT OF AGRICULTURE Pesticides Section 601 Delaware Pesticide Rules and Regulations ............................................................................... 1300 DEPARTMENT OF HEALTH AND SOCIAL SERVICES Division of Medicaid and Medical Assistance Attendant Services Program Section 1915(c) ................................................................................... 1301 DSSM 20400.9.1.1 Treatment of Special Needs Trusts ................................................................... 1302 DEPARTMENT OF INSURANCE 704 Homeowners Premium Consumer Comparison .............................................................................. 1304 1215 Recognition of Preferred Mortality Tables for Use in Determining Minimum Reserve Liabilities ... 1306 1501 Medicare Supplement Insurance Minimum Standards .................................................................. 1307 DEPARTMENT OF JUSTICE Division of Fraud and Consumer Protection Debt Management Services ............................................................................................................. 1308 DEPARTMENT OF STATE Division of Professional Regulation 1400 Board of Electrical Examiners ................................................................................................. 1329 GOVERNOR Executive Order No. 94 Declaring Tuesday, January 2, 2007 A Legal Holiday In Remembrance Of Former President Gerald R. Ford ........................................................................................................... 1331 Appointments ............................................................................................................................................. 1332 GENERAL NOTICES DEPARTMENT OF NATURAL RESOURCES AND ENVIRONMENTAL CONTROL Division of Air and Waste Management Delaware State Implementation Plan for Attainment of the 8-Hour Ozone National Ambient Air Quality Standard, Revision for Establishment of 2008 and 2009 Mobile Source Emission Budgets 1334 CALENDAR OF EVENTS/HEARING NOTICES Delaware River Basin Commission, Public Hearing and Business Meeting ............................................. 1336 Department of Education, Notice of Monthly Meeting ................................................................................ 1336 Dept. of Health and Social Services, Notice of Pubic Comment Periods Div. of Medicaid and Med. Assist., DSSM 20320 Ownership of Real Property; DSSM 20330.3 Promissory Notes, and DSSM 20330.7 U.S. Savings Bonds ................................................................................................ 1336 DSSM 20910.1 Institutionalized Spouse........................................................................................... 1337 Div. of Public Health, Notice of Pubic Comment Period 4104 Conrad State 30/J-1 Visa Waiver Program.............................................................................. 1337 Dept. of Insurance, Notice of Public Hearings 608 Automobile Insurance Coverage ..................................................................................................... 1337 1301 Internal Review, Arbitration and Independent Utilization Review of Health Insurance Claims ...... 1338 1403 Managed Care Organizations ........................................................................................................ 1338 DNREC, Div. of Air and Waste Management, Notice of Public Hearing........................................................ 1339 Div. of Air and Waste Management, Notice of Public Hearing ................................................................ 1340 Div. of Fish and Wildlife, Notice of Public Hearing .................................................................................. 1340 Dept. of State, Div. of Professional Regulation, Notice of Public Hearings Board of Occupational Therapy, ............................................................................................................ 1341 Board of Professional Land Surveyors,................................................................................................... 1341 Board of Examiners of Psychologists, .................................................................................................... 1342 COUNCIL ON POLICE TRAININGCouncil on Police Training.............................................................................................10 DE Reg. 341 (Final) DELAWARE MANUFACTURED HOME RELOCATION AUTHORITY201 Delaware Manufactured Home Relocation Trust Fund Regulations ......................10 DE Reg. 928 (Prop.) DELAWARE STATE FIRE PREVENTION COMMISSION2006 Delaware State Fire Prevention Regulations.......................................................10 DE Reg. 342 (Final) DEPARTMENT OF AGRICULTURE Delaware Agriculture Lands Preservation Foundation1301 Regulations Governing the Delaware Agricultural Forestlands Preservation Program ..........................................................................................................10 DE Reg. 9 (Prop.) 10 DE Reg. 825 (Final) Delaware Forest Service 402 State Forest Regulations ................................................................................10 DE Reg. 88 (Final) Harness Racing Commission 501 Harness Racing Rules and Regulations..........................................................10 DE Reg. 217 (Prop.) 10 DE Reg. 393 (Prop.) 10 DE Reg. 980 (Final) Sections 3.0, 5.0 and 8.0.................................................................................10 DE Reg. 931 (Prop.) 502 Delaware Standardbred Breeders Fund Regulations .....................................10 DE Reg. 982 (Final) Nutrient Management Commission1201 Nutrient Management Certification Regulations ........... ............................10 DE Reg. 411 (Prop.) 10 DE Reg. 1098 (Prop.) 1203 Mandatory Nutrient Management Plan Reporting Implementation Regulations................................................................................................10 DE Reg. 411 (Prop.) Pesticides Management601 Pesticide Rules and Regulations.....................................................................10 DE Reg. 236 (Prop.) 10 DE Reg. 833 (Final) Thoroughbred Racing Commission 1001 Thoroughbred Racing Rules and Regulations...............................................10 DE Reg. 27 (Prop.) 10 DE Reg. 546 (Final) 10 DE Reg. 1086 (Prop.) DEPARTMENT OF EDUCATION Office of the Secretary101 Delaware Student Testing Program.................................................................10 DE Reg. 245 (Prop.) 10 DE Reg. 676 (Final) 10 DE Reg. 1103 (Prop.) 103 Accountability for Schools, Districts and the State...........................................10 DE Reg. 89 (Final) 201 District and School Shared Decision Making...................................................10 DE Reg. 1140 (Final) 201 School Shared Decision Making Transition Planning Grants; 205 District Shared Decision Making Transition Planning Grants; 210 Approval of School Improvement Grants10 DE Reg. 773 (Prop.) 10 DE Reg. 1140 (Final) 247 Delaware Post Secondary Internship Program at the Washington Center (TWC) for Interships and Academic Seminars..................................................10 DE Reg. 779 (Prop.) 10 DE Reg. 1142 (Final) 284 Licensure and Certification of Public Education Employees in the Departmment....................................................................................................10 DE Reg. 600 (Prop.) 10 DE Reg. 983 (Final) 290 Approval of Teacher Education Programs........................................................10 DE Reg. 835 (Final) 292 Post Secondary Institutions and Degree Granting Institutions of Higher Education..........................................................................................................10 DE Reg. 850 (Final) 314 Certification Administrative Principal or Assistant Principal Administrator of Adult and Adult Alternative Education .............................................................10 DE Reg. 613 (Prop.) (Repealed)........................................................................................................10 DE Reg. 984 (Final) 320 Certification Adult Education Teacher .............................................................10 DE Reg. 613 (Prop.) (Repealed)........................................................................................................10 DE Reg. 984 (Final 371 Certification Teacher of the Hearing Impaired..................................................10 DE Reg. 781 (Prop.) 372 Certification Administrative Support Personnel (Formerly Secretarial Personnel).........................................................................................................10 DE Reg. 785 (Prop.) 10 DE Reg. 1143 (Final) 398 Degree Granting Institutions of Higher Education ...........................................10 DE Reg. 417 (Prop.) 399 Approval of Teacher Education Programs ......................................................10 DE Reg. 428 (Prop.) 502 Alignment of Local School District Curricula to the State Content Standards...10 DE Reg. 344 (Final) 503 Instructional Program Requirements ...............................................................10 DE Reg. 615 (Prop.) 10 DE Reg. 985 (Final) 505 High School Graduation Requirements and Diplomas.....................................10 DE Reg. 30 (Prop.) 10 DE Reg. 547 (Final) 745 Criminal Background Check for Public School Related Employment...............10 DE Reg. 253 (Prop.) 10 DE Reg. 684 (Final) 885 Safe Management and Disposal of Chemicals in the Delaware Public School System .................................................................................................10 DE Reg. 952 (Prop.) 910 Delaware General Educational Development (GED) Endorsement ...............10 DE Reg. 442 (Prop.) 10 DE Reg. 862 (Final) 915 James H. Groves High School ........................................................................10 DE Reg. 617 (Prop.) 10 DE Reg. 988 (Final) 1001 Participation in Extra Curricular Activities.......................................................10 DE Reg. 1112 (Prop.) 1103 Standards for School Bus Chassis and Bodies for Buses Placed in Production on or after January 1, 2007.............................................................10 DE Reg. 258 (Prop.) 10 DE Reg. 690 (Final) Professional Standards Board360 Certification Early Childhood Special Education Teacher.................................10 DE Reg. 1114 (Prop.) 1511 Issuance and Renewal of Continuing License................................................10 DE Reg. 97 (Final) 1521 Standard Certificate Agriculture Teacher........................................................10 DE Reg. 100 (Final) 1522 Standard Certificate Business Education Teacher..........................................10 DE Reg. 100 (Final) 1525 Standard Certificate English Teacher.............................................................10 DE Reg. 100 (Final) 1526 Standard Certificate English to Speakers of Other Languages......................10 DE Reg. 34 (Prop.) 10 DE Reg. 208(Errata) 10 DE Reg. 388(Errata) 10 DE Reg. 995 (Final) 1527 Endorsement English to Speakers of Other Languages (ESOL) Teacher......10 DE Reg. 38 (Prop.) (Repealed)........................................................................................................10 DE Reg. 999 (Final) 1528 Standard Certificate World Language Teacher Comprehensive.....................10 DE Reg. 100 (Final) 1534 Standard Certificate Mathematics Teacher Secondary...................................10 DE Reg. 100 (Final) 1537 Standard Certificate Bilingual Teacher K to 12 ..............................................10 DE Reg. 39 (Prop.) 10 DE Reg. 693 (Final) 1539 Standard Certificate Social Studies Teacher Secondary................................10 DE Reg. 100 (Final) 1540 Standard Certificate Science Teacher Secondary..........................................10 DE Reg. 100 (Final) 1541 Standard Certificate Mathematics Teacher Middle Level................................10 DE Reg. 100 (Final) 1542 Standard Certificate Science Teacher Middle Level......................................10 DE Reg. 100 (Final) 1543 Standard Certificate Art Teacher Comprehensive..........................................10 DE Reg. 100 (Final) 1548 Standard Certificate Music Teacher Comprehensive.....................................10 DE Reg. 100 (Final) 1551 Standard Certificate Physical Education Teacher Comprehensive................10 DE Reg. 100 (Final) 1554 Standard Certificate Reading Specialist.........................................................10 DE Reg. 100 (Final) 1556 Standard Certificate Elementary Teacher (Grades K-6)................................10 DE Reg. 100 (Final) 1558 Standard Certificate Bilingual Teacher (Spanish) Primary and Middle...........10 DE Reg. 44 (Prop.) 10 DE Reg. 695 (Final) 1561 Standard Certificate Teacher Exceptional Children Special Education Elementary, Repeal..........................................................................................10 DE Reg. 788 (Prop.) 1562 Standard Certificate Teacher Exceptional Children Special Education Secondary........................................................................................................10 DE Reg. 790 (Prop.) 1570 Standard Certificate Early Childhood Teacher Special Education ................10 DE Reg. 45 (Prop.) 10 DE Reg. 211(Errata) 10 DE Reg. 696 (Final) 1572 Standard Certificate Teacher of Students Who Are Deaf or Hard of Hearing10 DE Reg. 1144 (Final) 1579 Standard Certificate Teacher of the Visually Impaired ..................................10 DE Reg. 623 (Prop.) 10 DE Reg. 1147 (Final) DEPARTMENT OF FINANCE Division of RevenueAbandoned or Unclaimed Property Voluntary Disclosure Agreement and Audit Programs................................................................................................10 DE Reg. 1502 (Prop.) 10 DE Reg. 699 (Final) 301Publication of Tax Information...........................................................................10 DE Reg. 794 (Prop.) 10 DE Reg. 1116 (Prop.) DEPARTMENT OF HEALTH AND SOCIAL SERVICES Division of Long Term Care Residents ProtectionNursing Home Survey Process...............................................................................10 DE Reg. 6 (Emer.) Division of Medicaid and Medical AssistanceAssisted Living Medicaid 1915(c) Waiver ..............................................................10 DE Reg. 56 (Prop.) 10 DE Reg. 1001 (Final) Attendant Services Program ..................................................................................10 DE Reg. 954 (Prop.) Diamond State Health Plan 1115 Demonstration Waiver .......................................10 DE Reg. 55 (Prop.) 10 DE Reg. 549 (Final) Title XIX Medicaid State Plan, Supplement 3 to Attachment 2.6-A, Pg. 1, Reasonable Limits on Amounts for Necessary Medical or Remedial Care Not Covered Under Medicaid....................................................................10 DE Reg. 52 (Prop.) 10 DE Reg. 703 (Final) Title XIX, Transfer of Assets for Less Than Fair Market Value Made on or After February 8, 2006..............................................................................................10 DE Reg. 955 (Prop.) Title XXI Delaware Healthy Children State Program ..............................................10 DE Reg. 444 (Prop.) 10 DE Reg. 865 (Final) DSSM:20310 Long Term Care Medicaid ....................................................................10 DE Reg. 553 (Final) 20330.4, Retirement Funds..............................................................................10 DE Reg. 795 (Prop.) 20330.4.1, Annuities........................................................................................10 DE Reg. 798 (Prop.) 20350 Transfer of Assets ................................................................................10 DE Reg. 955 (Prop.) 20350.4, Multiple Transfers..............................................................................10 DE Reg. 1117 (Prop.) 20350.10, Long Term Care Medicaid, Exceptions to the Transfer of Assets...10 DE Reg. 50 (Prop.) 10 DE Reg. 558 (Final) 20400.5 Irrevocable Trusts ..............................................................................10 DE Reg. 955 (Prop.) 20400.9.1.1 Treatment of Special Needs Trusts .............................................10 DE Reg. 965 (Prop.) 20910.1 Long Term Care, Institutionalized Spouse ........................................10 DE Reg. 701 (Final) 20950 Initial Eligibility Determinations..............................................................10 DE Reg. 283 (Prop.) 20950 Initial Eligibility Determinations..............................................................10 DE Reg. 702 (Final) 20970 Fair Hearings.........................................................................................10 DE Reg. 283 (Prop.) 10 DE Reg. 702 (Final) 30000 Delaware Prescription Assistance Program ..........................................10 DE Reg. 446 (Prop.) 10 DE Reg. 866 (Final) 50100 Services Provided by the Chronic Renal Disease Program...................10 DE Reg. 347 (Final) Division of Social Services DSSM:3000 Temporary Assistance for Needy Families (TANF)..................................10 DE Reg. 286 (Prop.) 3001 Definitions................................................................................................10 DE Reg. 283 (Prop.) 10 DE Reg. 706 (Final) 3006 TANF Employment and Training Program...............................................10 DE Reg. 283 (Prop.) 10 DE Reg. 706 (Final) 3008 Eligibility of Certain Minors.......................................................................10 DE Reg. 283 (Prop.) 10 DE Reg. 706 (Final) 3012 School Attendance..................................................................................10 DE Reg. 283 (Prop.) 10 DE Reg. 706 (Final) 3031 Work for Your Welfare..............................................................................10 DE Reg. 283 (Prop.) 10 DE Reg. 706 (Final) 9013.1 Household Definition ............................................................................10 DE Reg. 626 (Prop.) 10 DE Reg. 1003 (Final) 9085 Reporting Changes .................................................................................10 DE Reg. 57 (Prop.) 10 DE Reg. 560 (Final) 11000 Child Care Subsidy Program..................................................................10 DE Reg. 447 (Prop.) 10 DE Reg. 564 (Final) 10 DE Reg. 1007 (Final) 15120 Financial Eligibility..................................................................................10 DE Reg. 143 (Final) 16230.1.2 Self-Employment Income.................................................................10 DE Reg. 143 (Final) 17300.3.2 Self-Employment Income.................................................................10 DE Reg. 143 (Final) 20210.16 Self Employment ..............................................................................10 DE Reg. 143 (Final) 20620.2 Necessary Medical Care Expenses....................................................10 DE Reg. 52 (Prop.) 10 DE Reg. 703 (Final) 20995.1 Post-Eligibility Deductions...................................................................10 DE Reg. 52 (Prop.) 10 DE Reg. 703 (Final) DEPARTMENT OF INSURANCE504 Continuing Education for Insurance Agents, Brokers, Surplus Lines Brokers and Consultants ......................................................................................................10 DE Reg. 60 (Prop.) 10 DE Reg. 734 (Final) 610 Automobile Premium Consumer Comparison ........................................................10 DE Reg. 62 (Prop.) 10 DE Reg. 566 (Final) 704 Homeowners Premium Consumer Comparison ....................................................10 DE Reg. 967 (Prop.) 1215 Recognition of Preferred Mortality Tables for Use in Determining Minimum Reserve Liabilities...................................................................................................10 DE Reg. 968 (Prop.) 1501 Medicare Supplement Insurance Minimum Standards.........................................10 DE Reg. 802 (Prop.) DEPARTMENT OF JUSTICE Division of Fraud and Consumer ProtectionDebt Management Services....................................................................................10 DE Reg. 804 (Prop.) Identity Theft Passports...........................................................................................10 DE Reg. 811 (Prop.) 10 DE Reg. 1151(Final) DEPARTMENT OF LABOR Division of Employment and Training106 Apprenticeship and Training Regulations ........................................................10 DE Reg. 64 (Prop.) (to be transferred to the Division of Industrial Affairs)10 DE Reg. 458 (Prop.) Division of Industrial Affairs 106 Apprenticeship and Training Regulations .......................................................10 DE Reg. 1021(Final) DEPARTMENT OF NATURAL RESOURCES AND ENVIRONMENTAL CONTROL Office of the Secretary106 Environmental Standards for Eligible Energy Resources................................10 DE Reg. 350 (Final) Division of Air and Waste Management1113 Open Burning.................................................................................................10 DE Reg. 1118 (Prop.) 1124 Control of Volatile Organic Compound Emissions, Section 46......................10 DE Reg. 813 (Prop.) 10 DE Reg. 867 (Final) 1141 Limiting Emissions of VOC from Consumer and Commercial Products .....10 DE Reg. 465 (Prop.) 10 DE Reg. 868 (Final) 1146 Electric Generating Unit (EGU) Multi-Pollutant Regulations .........................10 DE Reg. 508 (Prop.) 10 DE Reg. 1022 (Final) 1302 Regulations Governing Hazardous Waste.....................................................10 DE Reg. 353 (Final) Division of Fish and Wildlife3200 Horseshoe Crabs (3203, 3207, 3210, 3211 and 3214; 3215)........................10 DE Reg. 519 (Prop.) 10 DE Reg. 1029 (Final) 3536 Fish Pot Requirements (Formerly Tidal Finfish Reg. 24)...............................10 DE Reg. 629 (Prop.) 10 DE Reg. 1035 (Final) 3700 Shellfish Regulations (3711, 3712 and 3755) ...............................................10 DE Reg. 522 (Prop.) 10 DE Reg. 1034 (Final) Division of Soil and Water5101 Sediment and Stormwater Regulations (Exempt from A.P.A.) ......................10 DE Reg. 735 (Final) 5102 Regulation Governing Beach Protection and the Use of Beaches................10 DE Reg. 870 (Final) Division of Water Resources7402 Shellfish Sanitation Regulations ...................................................................10 DE Reg. 145 (Final) Watershed Assessment Section, Total Maximum Daily Loads (TMDLs) 7412 Chester River Watershed........................................................................10 DE Reg. 1041 (Final) 7413 Choptank River Watershed.....................................................................10 DE Reg. 1041 (Final) 7414 Marshyhope Creek Watershed...............................................................10 DE Reg. 1041 (Final) 7415 Pocomoke River Watershed...................................................................10 DE Reg. 1041 (Final) 7416 Army Creek Watershed...........................................................................10 DE Reg. 305 (Prop.) 10 DE Reg. 1042 (Final) 7417 Blackbird Creek Watershed....................................................................10 DE Reg. 1037 (Final) 7418 Broadkill River Watershed.......................................................................10 DE Reg. 1038 (Final) 7419 Cedar Creek Watershed..........................................................................10 DE Reg. 1038 (Final) 7420 Dragon Run Creek Watershed................................................................10 DE Reg. 305 (Prop.) 10 DE Reg. 1042 (Final) 7421 Leipsic River Watershed.........................................................................10 DE Reg. 1037 (Final) 7422 Little Creek Watershed............................................................................10 DE Reg. 1037 (Final) 7423 Mispillion River Watershed10 DE Reg. 1038 (Final) 7424 Red Lion Creek Watershed.....................................................................10 DE Reg. 305 (Prop.) 10 DE Reg. 1042 (Final) 7425 Smyrna River Watershed10 DE Reg. 1037 (Final) 7426 St. Jones River Watershed10 DE Reg. 1037 (Final) 7427 Appoquinimink River Watershed, Bacteria for, (formerly 7403)..............10 DE Reg. 524 (Prop.) 10 DE Reg. 1039 (Final) 7428 Murderkill River Watershed.....................................................................10 DE Reg. 524 (Prop.) 10 DE Reg. 1041 (Final) 7429 Inland Bays Drainage Basin ....................................................... .........10 DE Reg. 524 (Prop.) 10 DE Reg. 1041 (Final) 7430 Chesapeake Bay Drainage Basin...........................................................10 DE Reg. 524 (Prop.) 10 DE Reg. 1041 (Final) DEPARTMENT OF SAFETY AND HOMELAND SECURITY Board of Examiners of Private Investigators and Private Security Agencies1300 Board of Examiners of Private Investigators and Private Security Agencies 10 DE Reg. 971 (Prop.) DEPARTMENT OF SERVICES FOR CHILDREN, YOUTH AND THEIR FAMILIES Division of Family Services101 Day Care Centers.............................................................................................10 DE Reg. 308 (Prop.) DEPARTMENT OF STATE Division of Professional Regulation200 Board of Landscape Architects.........................................................................10 DE Reg. 1124 (Prop.) 500 Board of Podiatry..............................................................................................10 DE Reg. 309 (Prop.) 10 DE Reg. 1153 (Final) 700 Board of Chiropractic ................................................ ...............................10 DE Reg. 146 (Final) 10 DE Reg. 1126 (Prop.) 1400 Board of Electrical Examiners .......................................................................10 DE Reg. 631 (Prop.) 1770 Respiratory Care Advisory Council.................................................................10 DE Reg. 354 (Final) 1800 Board of Plumbing Examiners .......................................................................10 DE Reg. 65 (Prop.) 1900 Board of Nursing............................................................................................10 DE Reg. 1127 (Prop.) 2500 Board of Pharmacy.........................................................................................10 DE Reg. 311 (Prop.) Section 8.0, Requirements for Obtaining a Permit to Distribute Drugs on a Wholesale Basis ................................................................................10 DE Reg. 972 (Prop.) Section 9.0, Hospital Pharmacy........................................................................10 DE Reg. 821 (Prop.) 2600 Examining Board of Physical Therapists........................................................10 DE Reg. 318 (Prop.) 10 DE Reg. 741 (Final) 3000 Board of Professional Counselors of Mental Health and Chemical Dependency Professionals ..............................................................................10 DE Reg. 67 (Prop.) Section 6.0, Renewal of Licensure...................................................................10 DE Reg. 871 (Final) Sections 1.0 through 9.0, Reorganized and Renumbered................................10 DE Reg. 872 (Final) 3100 Delaware Board of Funeral Services .............................................................10 DE Reg. 528 (Prop.) 10 DE Reg. 1154 (Final) 3300 Board of Veterinary Medicine ........................................................................10 DE Reg. 531 (Prop.) 10 DE Reg. 884 (Final) 10 DE Reg. 1137 (Prop.) 3600 Board of Registration of Geologists ...............................................................10 DE Reg. 68 (Prop.) 10 DE Reg. 567 (Final) 3900 Board of Clinical Social Work Examiners.......................................................10 DE Reg. 323 (Prop.) 10 DE Reg. 886 (Final) 4400 Delaware Manufactured Home Installation Board..........................................10 DE Reg. 331 (Prop.) 10 DE Reg. 634 (Prop.) 10 DE Reg. 1156 (Final) 5300 State Board of Massage and Bodywork ........................................................10 DE Reg. 71 (Prop.) 10 DE Reg. 575 (Final) Office of the State Bank Commissioner1101 Election to be Treated for Tax Purposes as a "Subsidiary Corporation" of a DE Chartered Banking Organization or Trust Company, National Bank having its Principle Office in Delaware, or Out-of-State Bank that Operates Resulting Branch in Delaware ..........................................................................................10 DE Reg. 643 (Prop.) 1109 Instructions for Calculation of Employment Tax Credits ................................10 DE Reg. 643 (Prop.) 1113 Election by a Subsidiary Corporation of a Banking Organization or Trust Company to be Taxed in Accordance with Chapter 19 of Title 30 ...................10 DE Reg. 643 (Prop.) 1114 Alternative Franchise Tax ...............................................................................10 DE Reg. 643 (Prop.) Public Service CommissionRegulation Docket No. 49, Creation of a Competitive Market for Retail Electric Supply Service ..........................................................................10 DE Reg. 664 (Prop.) 10 DE Reg. 1160 (Final) Regulation Docket No. 50, Proposed Adoption of “Electric Service Reliability and Quality Standards” ...........................................................................................10 DE Reg. 74 (Prop.) 10 DE Reg. 576 (Final) Regulation Docket No. 56, Proposed Adoption of “Rules to Implement Renewable Energy Portfolio Standards”..........................................................10 DE Reg. 151 (Final) DEPARTMENT OF TRANSPORTATION Division of Planning and PolicyDevelopment Related Improvements Requiring New Rights-of-Way.....................10 DE Reg. 892 (Final) Utilities Manual Regulations...................................................................................10 DE Reg. 1139 (Prop.) Office of Motor Fuel Tax Administration2401 Regulations for the Office of Retail Gasoline Sales ......................................10 DE Reg. 542 (Prop.) GOVERNOR’S OFFICE Executive Orders:Executive Order No. 87, Establishing The State Employees’ Charitable Campaign ........................................................................................................10 DE Reg. 158 Executive Order No. 88, Recognizing and Establishing the Delaware Science and Technology Council...................................................................................10 DE Reg. 366 Executive Order No. 89,Creating the Governor’s Consortium on Hispanic Issues.10 DE Reg. 578 Executive Order No. 90, Establishing The Recycling Public Advisory Council.......10 DE Reg. 903 Executive Order No. 91, Amending Executive Order No. 84..................................10 DE Reg. 1067 Executive Order No. 92, Authorizing The Establishment Of A Special Fund To Assist Any Delaware National Guard Member Or Delaware-Based Reservist Who May Be Ordered To Active Duty..............................................................10 DE Reg. 1067 Executive Order No. 93, Amendment to Executive Order Number Eighty-Eight Regarding the Delaware Science and Technology Council.............................10 DE Reg. 1162 Appointments:10 DE Reg. 368 10 DE Reg. 905 DEPARTMENT OF INSURANCEStatutory Authority: 18 Delaware Code, Sections 311 and 332 (18 Del.C. §§ 311, 332 and 6401 et seq.) 18 DE Admin. Code 1301 EMERGENCY ORDER Pursuant to 29 Del.C. §10119, it is necessary to promulgate an amendment to Regulation 1301 relating to Internal Review, Arbitration and Independent Utilization Review of Health Insurance Claims. REASONS FOR EMERGENCY ACTION A.On July 6, 2006, Senate Bill 295 was enacted as 75 Del. Laws 362 transferring regulatory oversight of managed care organizations to the Department of Insurance (“Department”) from the Department of Health and Social Services. Sections 3 and 6 of the act provided for full implementation of the act by January 6, 2007. B.The transfer of regulatory authority created the need for substantial revisions to existing regulations currently in force as well as the need to make significant changes to the case handling system for medical insurance claims, reviews and arbitrations within the Department. C.The Department was not able to complete the process of amending the existing regulations, including the requirement to meet the publication and public notice provisions of the Delaware Administrative Procedures Act within the prescribed time limit. D.If an emergency regulation is not adopted, there is the potential that numerous claims will not be able to have the statutory review allowed by Delaware law and that Delaware citizens will be at risk of having benefits delayed or denied because there is no regulatory guidance to fill the gap as a result of the transfer of regulatory authority to the Department. E.The Department has completed the work necessary to submit the proposed amended regulations for public comment and by issuing this emergency order will permit a timely transition for the review of medical claims during the time required for public comment on the proposed regulatory amendments. DECISION AND ORDER 1.Regulation 1301 as currently promulgated is rescinded and the attached amended version of Regulation 1301 is substituted in lieu thereof effective January 6, 2007. 2.This order shall be effective until April 30, 2007 or until the attached amendment to Regulation 1301 is adopted pursuant to the Delaware Administrative Procedures Act whichever shall first occur. The Department will receive, consider and respond to petitions by any interested person for the reconsideration or revision of the emergency regulation. 3.The Department gives public notice of the proposed amendment to Regulation 1301 as required by 29 Del.C. §10115 as follows: PUBLIC NOTICE OF PROPOSED DEPARTMENT OF INSURANCE REGULATION RELATING TO INTERNAL REVIEW, ARBITRATION AND INDEPENDENT UTILIZATION REVIEW OF HEALTH INSURANCE CLAIMS INSURANCE COMMISSIONER MATTHEW DENN hereby gives notice of proposed amendments to Department of Insurance Regulation 1301 relating to Internal Review, Arbitration and Independent Utilization Review of Health Insurance Claims. The docket number for this proposed regulation is 356. The Department of Insurance proposes to amend Regulation 1301 by rescinding the current regulation and substituting in lieu thereof revised provisions for the review and arbitration of health insurance claims. As a result of the enactment of Senate Bill 295 on July 6, 2006, it became necessary to re-promulgate Regulation 1301 to provide for the review of claims from managed care organizations formerly under the regulatory authority of the Department of Health and Social Services. The Delaware Code authority for the change is 18 Del.C. §§ 311, 332 and 6401 et seq. The text can also be viewed at the Delaware Insurance Commissioner's website at www.delawareinsurance.gov and clicking on the link for "Proposed Regulations." The Department of Insurance will hold a public hearing on the proposed changes on February 26, 2007 at 10:00 a.m. in the Consumer Services hearing room, 841 Silver Lake Blvd., Dover, DE 19904. Any person can file written comments, suggestions, briefs, and compilations of data or other materials concerning the proposed amendment. Any written submission in response to this notice and relevant to the proposed change must be received by the Department of Insurance no later than 4:30 p.m., Tuesday, March 6, 2007 by delivering said comments to Deputy Attorney General Michael J. Rich, c/o Delaware Department of Insurance, 841 Silver Lake Boulevard, Dover, DE 19904, or sent by fax to 302.739.5566 or emailed to michael.rich@state.de.us. 4.Since the wording of the attached emergency regulation is identical to the wording the Department intends to adopt as a final regulation, public comment on the emergency regulation shall be deemed to be public comment on the proposed regulation as would otherwise be permitted under 29 Del.C. § 10115. IT IS SO ORDERED this 8th day of January, 2007 Matthew Denn, Insurance Commissioner 1301 Internal Review, Arbitration and Independent Utilization Review of Health Insurance Claims 1.0Purpose and Statutory Authority 1.1The purpose of this Regulation is to implement 18 Del.C. §§332, 6416 and 6417 which require health insurance carriers to establish a procedure for internal review of a carrier’s adverse coverage determination and which require the Delaware Insurance Department to establish and administer procedures for arbitration and independent utilization review upon completion of the carrier’s internal review process. This Regulation also implements 18 Del.C. §§3349 and 3565, which require the Delaware Insurance Department to establish and administer procedures for arbitration of disputes between health insurance carriers and non-network providers of emergency care services. This Regulation is promulgated pursuant to 18 Del.C. §§ 311, 332, 3349, 3565 and 6408 and 29 Del.C., Ch. 101. This Regulation should not be construed to create any cause of action not otherwise existing at law. 2.0Definitions 2.1The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise: “Adverse determination” means a decision by a carrier to deny (in whole or in part), reduce, limit or terminate health insurance benefits. “Appeal” means a request for external review of a carrier’s final coverage decision through the Independent Health Care Appeals Program. “Appropriateness of services” means an appeal classification for adverse determinations that are made based on identification of treatment as cosmetic, investigational, experimental or not an appropriate or preferred treatment method or setting for the condition for which treatment is sought. “Authorized representative” means an individual who a covered person willingly acknowledges to represent his interests during the internal review process, arbitration and/or an appeal through the Independent Health Care Appeals Program, including but not limited to a provider to whom a covered person has assigned the right to collect sums due from a carrier for health care services rendered by the provider to the covered person. A carrier may require the covered person to submit written verification of his consent to be represented. If a covered person has been determined by a physician to be incapable of assigning the right of representation, the covered person may be represented by a family member or a legal representative. “Carrier” means any entity that provides health insurance in this State. Carrier includes an insurance company, health service corporation, managed care organization and any other entity providing a plan of health insurance or health benefits subject to state insurance regulation. Carrier also includes any third-party administrator or other entity that adjusts, administers or settles claims in connection with health insurance. “Covered person” means an individual and/or family who has entered into a contractual arrangement, or on whose behalf a contractual arrangement has been entered into, with a carrier, pursuant to which the carrier provides health insurance for such person or persons. “Department” means the Delaware Insurance Department. “Emergency care provider” means a provider of emergency care services. “Emergency care services” means those services identified in 18 Del.C. §§3349(c) and 3565(c) including: A.Any covered service providing for the transportation of a patient to a hospital emergency facility for an emergency medical condition including air and sea ambulances so long as medical necessity criteria are met; and B. Facility and professional providers of emergency medical services in an approved emergency care facility. “Emergency medical condition” shall have the meaning assigned to it by 18 Del.C. §§3349(d) and 3565(d). “Final coverage decision” means the decision by a carrier at the conclusion of its internal review process upholding, modifying or reversing its adverse determination. “Grievance” means a request by a covered person or his authorized representative that a carrier review an adverse determination by means of the carrier’s internal review process. “Health care services” means any services or supplies included in the furnishing to any individual of medical or dental care, or hospitalization or incidental to the furnishing of such care or hospitalization, as well as the furnishing to any individual of any and all other services for the purpose of preventing, alleviating, curing or healing human illness, injury, disability or disease. “Health insurance” means a plan or policy issued by a carrier for the payment for, provision of, or reimbursement for health care services. “Independent Health Care Appeals Program (“IHCAP”)” means a program administered by the Department that provides for an external review by an Independent Utilization Review Organization of a carrier’s final coverage decision based on medical necessity or appropriateness of services. “Independent Utilization Review Organization (“IURO”)” means an entity that conducts independent external reviews of a carrier’s final coverage decisions resulting in a denial, termination, or other limitation of covered health care services based on medical necessity or appropriateness of services. “Internal review process (“IRP”)” means a procedure established by a carrier for internal review of an adverse determination. “Medical necessity” means providing of health care services or products that a prudent physician would provide to a patient for the purpose of diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: A.In accordance with generally accepted standards of medical practice; B.Consistent with the symptoms or treatment of the condition; and C.Not solely for anyone’s convenience. “Network carrier” is a carrier that has a written participation agreement with an emergency care provider to pay for emergency care services in Delaware. “Network emergency care provider” is an emergency care provider who has a written participation agreement with the carrier to provide emergency care services or governing payment of emergency care services in Delaware as of the date those services were provided. All other emergency care providers shall be considered non-network emergency care providers. “Provider” means an individual or entity, including without limitation, a licensed physician, a licensed nurse, a licensed physician assistant and a licensed nurse practitioner, a licensed diagnostic facility, a licensed clinical facility, and a licensed hospital, who or which provides health care services in this State. 3.0Minimum Requirements for an Internal Review Process (IRP) In addition to the requirements set forth in 18 Del.C. §332, the following provisions shall govern the internal review process of all carriers offering health insurance in Delaware: 3.1All written procedures and forms utilized by a carrier shall be readable and understandable by a person of average intelligence and education. All such documents shall meet the following criteria: 3.1.1The type size shall not be smaller than 11 point; 3.1.2The type style selection shall be at the discretion of the carrier but shall be of a type that is clear and legible; 3.1.3Captions or headings shall be designed to stand out clearly; 3.1.4White space separating subjects or sections should be distinct; 3.1.5There must be included a table of contents sufficient to guide and assist the covered person or his authorized representative; 3.1.6Where appropriate, definitions shall be included, shall be sufficient to clearly apply to the usage intended, and shall not conflict with the definitions contained in this regulation. 3.1.7The forms shall be written in everyday, conversational language to the extent possible to preserve the legal meaning. 3.1.8Short familiar words shall be used and sentences shall be kept as short and simple as possible. 3.2The carrier shall provide all forms relating to grievances, appeals, arbitration or other procedures relating to IRP as examples along with the written notice of IRP provided to the covered person. 3.3Written notice. 3.3.1For any IRP not previously approved by the Department, the carrier shall provide written notice of the IRP to all covered persons within 30 days of approval by the Department. 3.3.2The carrier shall provide the annual notice required by 18 Del.C. §332(c)(1) to covered persons either upon the policy renewal date, open enrollment date, or a set date for all covered persons, in the carrier’s discretion. 3.3.3For every new policy issued after the Department’s approval of the IRP, the carrier shall provide covered persons with a copy of the IRP at the time, or prior to the time, the carrier sends identification cards, member handbooks or similar member materials to newly covered persons. 3.3.4When a covered person’s dependents reside in the same household as the covered person, a single notice to the principal covered person shall be sufficient under this section. 3.4Under circumstances where an oral or written grievance may not contain sufficient information and the carrier requests additional information, such request shall not be burdensome or require such information as the carrier might reasonably be expected to obtain through its normal claims process. 4.0Mediation Services At the time a carrier provides to a covered person written notice of a carrier’s final coverage decision, if the decision does not authorize payment of the claim in its entirety, the carrier shall provide the covered person with a written notice of mediation services offered by the Department. Such notice may be separate from or a part of the written notice of the carrier’s decision. Any notice provided to a covered person shall, at a minimum, contain the following language: “You have the right to seek review of a claim denial through the Delaware Insurance Department. The Delaware Insurance Department also provides free informal mediation services which are in addition to, but do not replace, your right to review of this decision. You can contact the Delaware Insurance Department for information about claim denial review or mediation by calling the Consumer Services Division at 800-282-8611 or 302-739-4251. You may go to the Delaware Insurance Department at The Rodney Building, 841 Silver Lake Blvd., Dover, DE 19904 between the hours of 8:30 a.m. and 4:00 p.m. to personally discuss the review or mediation process. All requests for review through procedures established by the Delaware Insurance Department must be filed within 60 days from the date you receive this notice; otherwise, this decision will be final.” 5.0Options for External Review of a Carrier's Final Coverage Decision 5.1A covered person or his authorized representative may request review of a carrier’s final coverage decision through the Department by filing either a Petition for Arbitration or filing an appeal through the Independent Health Care Appeals Program, depending on the basis for the carrier’s final coverage decision as set forth herein. 5.2Arbitration (sections 6.0 and 7.0 of this regulation). Except for claims exempt from arbitration by law or regulation, every carrier, provider, network emergency care provider and non-network emergency care provider as defined in this regulation shall submit to arbitration the following: 5.2.1covered claims arising from the provision of emergency care services under 18 Del.C. §§3349 and 3565; and 5.2.2final coverage decisions denying claims based on grounds other than medical necessity or appropriateness of services. 5.3Independent Health Care Appeals Program (sections 8.0 through 11.0 of this regulation). A carrier shall submit all requests for review of final coverage decisions denying claims based, in whole or in part, on medical necessity or appropriateness of services (“appeals”) to the Independent Health Care Appeals Program (“IHCAP”). 5.3.1For cases in which a carrier’s final coverage decision should be reviewed through arbitration and through IHCAP, or where there is an ambiguity as to whether review should be through arbitration or through IHCAP, review shall be conducted through IHCAP. 5.4Exemption from Arbitration. 18 Del.C. §§3349(b) and 3565(b) shall not apply to health insurance policies exempt from state regulation under federal law or regulation. On a quarterly basis, each carrier shall provide a list of non-exempt plan numbers to the Department. The Department shall maintain a public register of such non-exempt plan numbers. The placement of a non-exempt plan number on the register shall constitute a rebuttable presumption that such non-exempt plan number is subject to the provisions of this regulation. A carrier that clearly identifies whether a plan is either exempt or non-exempt on the face of an identification or membership card shall not be required to comply with the provisions of this sub-section but only with respect to the plans for which such identification or membership cards display the group status. 5.5The provisions of this regulation shall not apply to Medicaid or any other health insurance program where the review of coverage determinations is otherwise regulated by the provisions of other state or federal laws or regulations. 6.0Arbitration Procedure 6.1Petition for Arbitration 6.1.1A covered person or his authorized representative may request review of a carrier’s final coverage decision through arbitration by delivering a Petition for Arbitration to the Department so that it is received by the Department no later than 60 days after the covered person’s receipt of written notice of the carrier’s final coverage decision. 6.1.2A covered person or his authorized representative must deliver to the Department an original and three copies of the Petition for Arbitration. 6.1.3At the time of delivering the Petition for Arbitration to the Department, a covered person or his authorized representative must also: 6.1.3.1send a copy of the Petition to the carrier by certified mail, return receipt requested; 6.1.3.2deliver to the Department a Proof of Service confirming that a copy of the Petition has been sent to the carrier by certified mail, return receipt requested; and 6.1.3.3deliver to the Department a non-refundable $75.00 filing fee. 6.1.4The Department may refuse to accept any Petition that is not timely filed or does not otherwise meet the criteria for arbitration. If the subject of the Petition is appropriate for review through IHCAP, the Department shall advise the covered person or his authorized representative of the procedure to obtain IHCAP review. If the subject of the Petition is appropriate for IHCAP review, the Petition for Arbitration will be treated as an IHCAP appeal for purposes of determining whether the IHCAP appeal is timely filed in accordance with section 8.1 of this regulation. 6.2Response to Petition for Arbitration 6.2.1Within 20 days of receipt of the Petition, the carrier must deliver to the Department an original and three copies of a Response with supporting documents or other evidence attached. 6.2.2At the time of delivering the Response to the Department, the carrier must also: 6.2.2.1send a copy of the Response and supporting documentation to the covered person or his authorized representative by first class U.S. mail, postage prepaid; and 6.2.2.2deliver to the Department a Proof of Service confirming that a copy of the Response was mailed to the covered person or his authorized representative. 6.2.3The Department may return any non-conforming Response to the carrier. 6.2.4If the carrier fails to deliver a Response to the Department in a timely fashion, the Department, after verifying proper service, and with written notice to the parties, may assign the matter to the next scheduled Arbitrator for summary disposition. 6.2.4.1The Arbitrator may determine the matter in the nature of a default judgment after establishing that the Petition is properly supported and was properly served on the carrier. 6.2.4.2 The Arbitrator may allow the re-opening of the matter to prevent a manifest injustice. A request for re-opening must be made no later than seven days after notice of the default judgment. 6.3Summary Dismissal of Petition by the Department 6.3.1If the Department determines that the subject of the Petition is not appropriate for arbitration or IHCAP or is meritless on its face, the Department may summarily dismiss the Petition and provide notice of such dismissal to the parties. 6.4Appointment of Arbitrator 6.4.1Upon receipt of a proper Response, the Department shall assign an Arbitrator who shall schedule the matter for a hearing so that the Arbitrator can render a written decision within 45 days of the delivery to the Department of the Petition for Arbitration. 6.4.2The Arbitrator shall be of suitable background and experience to decide the matter in dispute and shall not be affiliated with any of the parties or with the provider whose service is at issue in the dispute. 6.5Arbitration Hearing 6.5.1The Arbitrator shall give notice of the arbitration hearing date to the parties at least 10 days prior to the hearing. The parties are not required to appear and may rely on the papers delivered to the Department. 6.5.2The arbitration hearing is to be limited, to the maximum extent possible, to each party being given the opportunity to explain their view of the previously submitted evidence and to answer questions by the Arbitrator. 6.5.3If the Arbitrator allows any brief testimony, the Arbitrator shall allow brief cross-examination or other response by the opposing party. 6.5.4The Delaware Uniform Rules of Evidence will be used for general guidance but will not be strictly applied. 6.5.5Because the testimony may involve evidence relating to personal health information that is confidential and protected by state or federal laws from public disclosure, the arbitration hearing shall be closed unless otherwise agreed by the parties. 6.5.6The Arbitrator may contact, with the parties' consent, individuals or entities identified in the papers by telephone in or outside of the parties' presence for information to resolve the matter. 6.5.7The Arbitrator is to consider the matter based on the submissions of the parties and information otherwise obtained by the Arbitrator in accordance with this regulation. The Arbitrator shall not consider any matter not contained in the original or supplemental submissions of the parties that has not been provided to the opposing party with at least five days notice, except claims of a continuing nature that are set out in the filed papers. 6.6Arbitrator’s Written Decision. 6.6.1The Arbitrator shall render his decision and mail a copy of the decision to the parties within 45 days of the filing of the Petition. 6.6.2The Arbitrator’s decision is binding upon the carrier except as provided in 18 Del.C.§332(g). 6.7Arbitration Costs. 6.7.1In arbitrations commenced under 18 Del.C. §332, the carrier shall pay the costs and fees of arbitration which exceed the non-refundable filing fee of $75.00 required to commence arbitration. 6.7.2In arbitrations commenced under 18 Del.C. §§3349 or 3565, the non-prevailing party(ies) shall pay the costs and fees of arbitration which exceed the non-refundable filing fee of $75.00 required to commence arbitration. 7.0Special Provisions Applicable to Arbitration Pursuant to 18 Del. C. §§3349 and 3565 7.1In any arbitration pursuant to 18 Del.C. §§3349 or 3565, the Arbitrator shall, at a minimum, receive evidence relating to the following items: 7.1.1The highest amount of money paid by the carrier to any emergency care provider for the particular service in a comparable medical facility where the service was provided during the preceding twelve months; 7.1.2The lowest amount of money paid by the carrier to any emergency care provider for the particular service in a comparable medical facility where the service was provided during the preceding twelve months; 7.1.3The highest amount of money received by the non-network emergency care provider from any carrier for the particular service in a comparable medical facility where the service was provided during the preceding twelve months; 7.1.4The lowest amount of money received by the non-network emergency care provider from any carrier for the particular service in a comparable medical facility where the service was provided during the preceding twelve months; 7.1.5The number of times during the preceding twelve months that the carrier experienced a dispute or disagreement with respect to the payment for the particular service in a comparable medical facility where the service was provided, and the outcome of such disputes or disagreements. 7.2The information specified in section 7.1 of this regulation and provided to the Arbitrator shall presumptively be considered trade secret or confidential financial information under the Delaware Freedom of Information Act and shall not be disclosed to or available at any time to any person, firm or entity not involved in the arbitration. 7.3The Arbitrator shall consider the following guidelines as a basis for determining the rate or charge for a disputed service unless the evidence adduced at arbitration requires a determination on a different basis: 7.3.1Payments for emergency care services with CPT codes. A carrier shall pay non-network emergency care providers an amount equal to the lesser of the non-network emergency care provider billed fee for such service or the highest negotiated rate between the carrier and any network provider for the service based on the appropriate CPT code until such time as the non-network provider becomes a network provider pursuant to a written participation agreement. Thereafter payments will be based on the new negotiated rates. 7.3.2Payments for emergency care services without CPT codes. For emergency care services that do not have a CPT code or other identifiable code number, a carrier shall pay non-network emergency care providers the lesser of the non-network emergency care provider billed fee, or the highest negotiated network rate received by the non-network provider from any carrier for the performance of the same service. When and if the non-network provider becomes a network provider, payments will be based on the negotiated rate. 7.3.3Changes in the membership of a provider group will not affect the remaining group member(s) insofar as the application of this section to payments for emergency care services. In the absence of a contract provision to the contrary, a physician’s existing network status and payment rights shall not be transferable to that physician’s new group or practice. 8.0IHCAP Procedure 8.1A covered person or his authorized representative may request review of a final coverage decision based on medical necessity or appropriateness of services by filing an appeal with the carrier within 60 days of receipt of the final coverage decision. 8.2Upon receipt of an appeal, the carrier shall transmit the appeal electronically or by facsimile to the Department as soon as possible, but within no more than three business days, and shall send a hard copy of the request to the Department by mail. 8.3Within five calendar days of receipt of an appeal, the Department shall assign an approved, impartial Independent Utilization Review Organization to review the final coverage decision and shall notify the carrier. 8.4The assigned IURO shall, within five calendar days of assignment, notify the covered person or his authorized representative in writing by certified or registered mail that the appeal has been accepted for external review. 8.4.1The notice shall include a provision stating that the covered person or his authorized representative may submit additional written information and supporting documentation that the IURO shall consider when conducting the external review. 8.4.2The covered person or his authorized representative shall submit such written documentation to the IURO within seven calendar days following the date of receipt of the notice. 8.4.3Upon receipt of any information submitted by the covered person or his authorized representative, the assigned IURO shall as soon as possible, but within no more than two business days, forward the information to the carrier. 8.4.4The IURO must accept additional documentation submitted by the carrier in response to additional written information and supporting documentation from the covered person or his authorized representative. 8.5Within seven calendar days after the receipt of the notification required in section 8.3, the carrier shall provide to the assigned IURO the documents and any information considered in making the final coverage decision. 8.5.1If the carrier fails to submit documentation and information or fails to participate within the time specified, the assigned IURO may terminate the external review and make a decision, with the approval of the Department, to reverse the final coverage decision. 8.6The external review may be terminated if the carrier decides to reverse its final coverage decision and provide coverage or payment for the health care service that is the subject of the appeal. 8.6.1Immediately upon making the decision to reverse its final coverage decision, the carrier shall notify the covered person or his authorized representative, the assigned IURO, and the Department in writing of its decision. The assigned IURO shall terminate the external review upon receipt of the written notice from the carrier. 8.7Within 45 days after the IURO’s receipt of an appeal, the assigned IURO shall provide written notice of its decision to uphold or reverse the final coverage decision to the covered person or his authorized representative, the carrier and the Department, which notice shall include the following information: 8.7.1the qualifications of the members of the review panel; 8.7.2a general description of the reason for the request for external review; 8.7.3the date the IURO received the assignment from the Department to conduct the external review; 8.7.4the date(s) the external review was conducted; 8.7.5the date of its decision; 8.7.6the principal reason(s) for its decision; and 8.7.7references to the evidence or documentation, including practice guidelines and clinical review criteria, considered in reaching its decision. 8.8The decision of the IURO is binding upon the carrier except as provided in 18 Del.C. §6416(b). 9.0Expedited IHCAP Procedure 9.1A covered person or his authorized representative may request an expedited appeal at the time the carrier issues its final coverage decision if the covered person suffers from a condition that poses an imminent, emergent or serious threat or has an emergency medical condition. 9.2At the time the carrier receives request for an expedited appeal, the carrier shall immediately transmit the appeal electronically or by facsimile to the Department and shall send a hard copy to the Department by mail. 9.3If the Department determines that the review meets the criteria for expedited review, the Department shall assign an approved, impartial IURO to conduct the external review and shall notify the carrier. 9.4At the time the carrier receives the notification of the assigned IURO, the carrier shall provide or transmit all necessary documents and information considered in making its final coverage decision to the assigned IURO electronically, by telephone, by facsimile or any other available expeditious method. 9.5As expeditiously as the covered person’s medical condition permits or circumstances require, but in no event more than 72 hours after the IURO’s receipt of the expedited appeal, the IURO shall make a decision to uphold or reverse the final coverage decision and immediately notify the covered person or his authorized representative, the carrier, and the Department of the decision. 9.6Within two calendar days of the immediate notification, the assigned IURO shall provide written confirmation of its decision to the covered person or his authorized representative, the carrier, and the Department. 9.7The decision of the IURO is binding upon the carrier except as provided in 18 Del.C. §6416(b). 10.0Refusal or Dismissal of IHCAP Appeal 10.1 The Department may refuse to accept any appeal that is not timely filed or does not otherwise meet the criteria for IHCAP review. If the subject of the appeal is appropriate for arbitration, the Department shall advise the covered person or his authorized representative of the arbitration procedure. If the subject of the appeal is appropriate for arbitration, the appeal shall be treated as a Petition for Arbitration for purposes of determining whether the Petition is timely filed in accordance with section 6.1.1 of this regulation. 10.2Carrier’s motion to dismiss an IHCAP appeal. 10.2.1A carrier may move to dismiss an IHCAP appeal if the carrier believes: 10.2.1.1the appeal concerns a benefit that is the subject of an express written exclusion from the covered person’s health insurance; 10.2.1.2the appeal is appropriate for arbitration; or 10.2.1.3the appeal should be dismissed because it is inappropriate for IHCAP review as explained in a sworn statement by an officer of the carrier. 10.2.2The carrier’s motion to dismiss must be made in writing at the time the carrier transmits the appeal to the Department and must include any necessary supporting documentation. 10.2.3The Department shall review the appeal and motion for dismissal and may, in its discretion: 10.2.3.1dismiss the appeal and notify the covered person or his authorized representative in writing that the appeal is inappropriate for the IHCAP; or 10.2.3.2 appoint an IURO to conduct a full external review. 11.0IHCAP Costs 11.1All costs for IHCAP review by an IURO, whether the review is preliminary, or partially or fully completed, shall be borne by the carrier. 11.2The carrier shall reimburse the Department for the cost of the IHCAP review within 90 calendar days of receipt of the decision by the IURO or within 90 days of termination of review by the IURO by other means. 12.0Approval of Independent Utilization Review Organizations 12.1The Department shall approve IUROs eligible to be assigned to conduct IHCAP reviews as provided in 18 Del.C. §6417(a). 12.2An IURO seeking approval to conduct IHCAP reviews shall submit an application to the Department that includes the information required by 18 Del.C. §§6417(c)(1), 6417(c)(2), 6417(c)(4) and 6417(c)(4)(d). 12.3The Department shall maintain a current list of approved IUROs. 13.0Carrier Recordkeeping and Reporting Requirements 13.1A carrier shall maintain written or electronic records documenting all grievances, Petitions for Arbitration and appeals for IHCAP review including, at a minimum, the following information: 13.1.1For each grievance: 13.1.1.1 the date received; 13.1.1.2name and plan identification number of the covered person on whose behalf the grievance was filed; 13.1.1.3 a general description of the reason for the grievance; and 13.1.1.4 the date and description of the final coverage decision. 13.1.2For each Petition for Arbitration: 13.1.2.1 the date the Petition was filed; 13.1.2.2name and plan identification number of the covered person on whose behalf the Petition was filed; 13.1.2.3 a general description of the reason for the Petition; and 13.1.2.4date and description of the Arbitrator’s decision or other disposition of the Petition. 13.1.3For each appeal for IHCAP review: 13.1.3.1 the date received; 13.1.3.2name and plan identification number of the covered person on whose behalf the appeal was filed; 13.1.3.3 a general description of the reason for the appeal; and 13.1.3.4 date and description of the IURO’s decision or other disposition of the appeal. 13.2A carrier shall file with its annual report to the Department the following information: 13.2.1The total number grievances filed. 13.2.2The total number of Petitions for Arbitration filed, with a breakdown showing: 13.2.2.1 the total number of final coverage decisions upheld through arbitration; and 13.2.2.2 the total number of final coverage decisions reversed through arbitration. 13.2.3The total number of IHCAP appeals filed, with a breakdown showing: 13.2.3.1 the total number of final coverage decisions upheld through IHCAP; and 13.2.3.2 the total number of final coverage decisions reversed through IHCAP. 13.3A carrier shall make available to the Department upon request any of the information specified in the foregoing sections 13.1 and 13.2, and other information regarding its internal review process including but not limited to the written IRP procedures and forms the carrier distributes to covered persons. 14.0Non-Retaliation 14.1A carrier shall not disenroll, terminate or in any way penalize a covered person who exercises his rights to file a grievance, Petition for Arbitration or appeal for IHCAP review solely on the basis of such filing. 14.2A carrier shall not terminate or in any way penalize a provider with whom it has a contractual relationship and who exercises, on behalf of a covered person, the right to file a grievance, Petition for Arbitration or appeal for IHCAP review solely on the basis of such filing. 15.0Confidentiality of Health Information 15.1Nothing in this Regulation shall supersede any federal or state law or regulation governing the privacy of health information. 16.0Effective Date 16.1This regulation shall become effective on April 11, 2007. Pursuant to the order of the Commissioner dated January 8, 2007, any claim filed for review or arbitration after January 8, shall be governed by this regulation. Any claim filed for review or arbitration prior to January 8, 2007 under the version of this regulation adopted February 15, 2002 and not resolved prior to January 8, 2007 shall be governed by the February 15, 2002 version of this regulation. DEPARTMENT OF INSURANCEStatutory Authority: 18 Delaware Code, Sections 311 and 332 (18 Del.C. §§ 311 and 6401 et seq.) 18 DE Admin. Code 1403 EMERGENCY ORDER Pursuant to 29 Del.C. §10119, it is necessary to promulgate an amendment to Regulation 1403 relating to Managed Care Organizations. REASONS FOR EMERGENCY ACTION A.On July 6, 2006, Senate Bill 295 was enacted as 75 Del. Laws 362 transferring regulatory oversight of managed care organizations to the Department of Insurance (“Department”) from the Department of Health and Social Services. Sections 3 and 6 of the act provided for full implementation of the act by January 6, 2007. B.The transfer of regulatory authority created the need for substantial revisions to existing regulations currently in force as well as the need to make significant changes to the case handling system for medical insurance claims, reviews and arbitrations within the Department. C.The Department was not able to complete the process of amending the existing regulations, including the requirement to meet the publication and public notice provisions of the Delaware Administrative Procedures Act within the prescribed time limit. D.If an emergency regulation is not adopted, there is the potential that numerous claims will not be able to have the statutory review allowed by Delaware law, that there would be a void in the regulatory provisions governing the operation of managed care organizations and that Delaware citizens will be at risk of having benefits delayed or denied because there is no regulatory guidance to fill the gap as a result of the transfer of regulatory authority to the Department. E.The Department has completed the work necessary to submit the proposed amended regulations for public comment and by issuing this emergency order will permit a timely transition for the review of medical claims during the time required for public comment on the proposed regulatory amendments. DECISION AND ORDER 1.Regulation 1403 as currently promulgated is rescinded and the attached amended version of Regulation 1403 is substituted in lieu thereof effective January 6, 2007. 2.This order shall be effective until April 30, 2007 or until the attached amendment to Regulation 1403 is adopted pursuant to the Delaware Administrative Procedures Act whichever shall first occur. The Department will receive, consider and respond to petitions by any interested person for the reconsideration or revision of the emergency regulation. 3.The Department gives public notice of the proposed amendment to Regulation 1403 as required by 29 Del.C. §10115 as follows: PUBLIC NOTICE OF PROPOSED DEPARTMENT OF INSURANCE REGULATION RELATING TO MANAGED CARE ORGANIZATIONS INSURANCE COMMISSIONER MATTHEW DENN hereby gives notice of proposed Department of Insurance Regulation 1403 relating to Managed Care Organizations. The docket number for this proposed regulation is 357. The Department of Insurance proposes to amend Regulation 1403 by rescinding the current regulation and substituting in lieu thereof revised provisions relating to the regulation of Managed Care Organizations. As a result of the enactment of Senate Bill 295 on July 6, 2006, it became necessary to re-promulgate Regulation 1403 to provide for the regulation of managed care organizations formerly under the regulatory authority of the Department of Health and Social Services. The Delaware Code authority for the change is 18 Del. C. §§ 311 and 6401 et seq. The text can also be viewed at the Delaware Insurance Commissioner's website at www.delawareinsurance.gov and clicking on the link for "Proposed Regulations." The Department of Insurance will hold a public hearing on the proposed changes on February 26, 2007 at 10:00 a.m. in the Consumer Services hearing room, 841 Silver Lake Blvd., Dover, DE 19904. Any person can file written comments, suggestions, briefs, and compilations of data or other materials concerning the proposed amendment. Any written submission in response to this notice and relevant to the proposed change must be received by the Department of Insurance no later than 4:30 p.m., Tuesday, March 6, 2007 by delivering said comments to Deputy Attorney General Michael J. Rich, c/o Delaware Department of Insurance, 841 Silver Lake Boulevard, Dover, DE 19904, or sent by fax to 302.739.5566 or emailed to michael.rich@state.de.us. 4.Since the wording of the attached emergency regulation is identical to the wording the Department intends to adopt as a final regulation, public comment on the emergency regulation shall be deemed to be public comment on the proposed regulation as would otherwise be permitted under 29 Del. C. § 10115 IT IS SO ORDERED this 8th day of January, 2007 Matthew Denn, Insurance Commissioner 1403 Health Maintenance Organizations [Formerly Regulation 58]1.0Purpose and Statutory Authority 1.1The purpose of this Regulation is to implement 18 Del.C. Ch. 64, as amended effective July 6, 2006, which transferred regulatory authority over Managed Care Organizations from the Department of Health and Social Services to the Department of Insurance. This Regulation is promulgated pursuant to 18 Del.C. §6408 and 29 Del.C. Ch. 101. 2.0Definitions The following words and terms, when used in this regulation, should have the following meaning unless the context clearly indicates otherwise: “Adverse determination” means a decision by an MCO to deny (in whole or in part), reduce, limit or terminate benefits under a health care contract. “Appeal” means a request for external review of an MCO’s determination resulting in a denial, termination or other limitations of covered health services based on medical necessity or appropriateness of services “Appropriateness of services” means an appeal classification for adverse determinations that are made based on identification of treatment as cosmetic, investigational, experimental or not an appropriate or preferred treatment method or setting for the condition for which treatment is sought. “Balance billing” means a health care provider’s demand that a patient pay a greater amount for a given service than the amount the individual’s insurer, managed care organization, or health service corporation has paid or will pay for the service. “Basic Health Services” means a range of health care services, including at least the following: A.Physician services, including consultant and referral services, by a physician licensed by the State of Delaware; B.At least 365 days of inpatient hospital services; C.Medically necessary emergency health services; D.Diagnostic laboratory services; E.Diagnostic and therapeutic radiological services; F.Preventive health services; and G.Emergency out-of-area and out-of-network coverage. “Carrier” means any entity that provides health insurance in this State. Carrier includes an insurance company, health service corporation, managed care organization and any other entity providing a plan of health insurance or health benefits subject to state insurance regulation. Carrier also includes any third-party administrator or other entity that adjusts, administers or settles claims in connection with health insurance. “Certificate of Authority” means the authorization by the Department to operate the MCO. This certificate shall be deemed to be a license to operate such an organization. “Chief Executive Officer” means the individual employed to manage and direct the activities of the MCO. “Covered health services” means services that are included in the enrollee’s health care contract with the carrier. “Covered Person”: see “Enrollee.” “Department” means the Delaware Department of Insurance. “Emergency care” means health care items or services furnished or required to evaluate or treat an emergency medical condition. “Emergency medical condition” means a medical or behavioral condition, the onset of which is sudden, that manifests itself by symptoms of sufficient severity including, but not limited to, severe pain, that a prudent layperson, possessing an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in: A.Placing the health of the individual afflicted with such condition (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy, or in the case of a behavioral condition, placing the health of such person or others in serious jeopardy; B.Serious impairment to bodily functions; C.Serious impairment or dysfunction of any bodily organ or part; or D.Serious disfigurement of such person. “Enrollee” means an individual and/or family who has entered into a contractual arrangement, or on whose behalf a contractual arrangement has been entered into with the MCO, under which the MCO assumes the responsibility to provide to such person(s) coverage for basic health services and such supplemental health services as are enumerated in the health care contract. “Geographically accessible” means a location no greater than 30 miles or 40 minutes driving time from 90% of enrollees within MCO’s geographic service area. “Geographic service area” means the stated primary geographical area served by an MCO. The primary area served shall be a radius of not more than 20 miles or more than 30 minutes driving time from a primary care office operated or contracted by the MCO. “Grievance” means a request by an enrollee that an MCO review an adverse determination by means of the MCO’s internal review process. “Health care contract” means any agreement between an MCO and an enrollee or group plan which sets forth the services to be supplied to the enrollee in exchange for payments made by the enrollee or group plan. “Health care professional” means an individual engaged in the delivery of health care services as licensed or certified by the State of Delaware. “Health care services” means any services included in the furnishing to any individual of medical or dental care, or hospitalization or incidental to the furnishing of such care or hospitalization, as well as the furnishing to any person of any and all other services for the purpose of preventing, alleviating, curing or healing human illness, injury or physical disability. “Independent Health Care Appeals Program” means a program administered by the Department which provides for a review by an Independent Utilization Review Organization. “Independent Utilization Review Organization (IURO)” means an entity that conducts independent external reviews of a carrier’s determinations resulting in a denial, termination, or other limitation of covered health care services based on medical necessity or appropriateness of services. “Intermediary” means a person authorized to negotiate and execute provider contracts with MCOs on behalf of health care providers or on behalf of a network. “Internal review process” means a procedure established by an MCO for internal review of an adverse determination. “Level 1 trauma center” means a regional resource trauma center that has the capability of providing leadership and comprehensive, definitive care for every aspect of injury from prevention through rehabilitation. “Level 2 trauma center” means a regional trauma center with the capability to provide initial care for all trauma patients. Most patients would continue to be cared for in this center; there may be some complex cases which would require transfer for the depth of services of a regional Level 1 or specialty center. “Managed Care Organization (MCO)” means a public or private organization, organized under the laws of any state, which: A.Provides or otherwise makes available to enrollees health care services, including at least the basic health services defined in this section; B.Is primarily compensated (except for co-payment) for the provision of basic health services to enrollee on a predetermined periodic rate basis; and C.Provides physician services. An MCO may also arrange for health care services on a prepayment or other financial basis. “Medical necessity” means providing of covered health services or products that a prudent physician would provide to a patient for the purpose of diagnosing, or treating an illness, injury, disease or its symptoms in a manner that is: A.In accordance with generally accepted standards of medical practice; B.Consistent with the symptoms or treatment of the condition; and C.Not solely for anyone’s convenience. “Network” means the participating providers delivering services to enrollees. “Office” means any facility where enrollees receive primary care or other health care services. “Out of area coverage” means health care services provided outside the MCO’s geographic service areas with appropriate limitations and guidelines acceptable to the Department. At a minimum, such coverage must include emergency care. “Participating provider” means a provider who, under a contract with the MCO or with its contractor or sub contractor, has agreed to provide health care services to enrollees with an expectation of receiving payment, other than coinsurance, co-payments or deductibles, directly or indirectly from the MCO. “Premium” means payment(s) called for in the health care contract which must be: A.Paid or arranged for by, or on behalf of, the enrollee before health care services are rendered by the MCO; B.Paid on a periodic basis without regard to the date on which health care services are rendered; and C.With respect to an individual enrollee, are fixed without regard to frequency, extent or cost of health services actually furnished. “Primary care physician (PCP)” means a participating physician chosen by the enrollee and designated by the MCO to supervise, coordinate, or provide initial care or continuing care to an enrollee, and who may be required by the MCO to initiate a referral for specialty care and maintain supervision of health care services rendered to the enrollee. “Provider” means a health care professional or facility. “Staff Model MCO” means an MCO in which physicians are employed directly by the MCO or in which the MCO directly operates facilities which provide health care services to enrollees. “Tertiary services” means health care services provided for the intensive treatment of critically ill patients who require extraordinary care on a concentrated basis in special diagnostic categories (e.g., burns, cardiovascular, neonatal, pediatric, oncology, transplants, etc.). “Utilization review” means a set of formal techniques designed to monitor the use of, or evaluate the clinical necessity, efficacy, and/or efficiency of, health care services, procedures or settings. Techniques may include ambulatory review, prospective review, second opinion, certification, concurrent review, case management, discharge planning, or retrospective review. 3.0Certificate of Authority 3.1Each application for a Certificate of Authority as a Managed Care Organization shall be made on Form No. H-1 entitled "Application for Certificate of Authority as a Managed Care Organization" (Exhibit A to this regulation). The application shall be accompanied by the following: 3.1.1The information specified in 18 Del.C. §6404(a); 3.1.2Evidence of accreditation by a nationally-recognized managed care accrediting organization such as the National Committee for Quality Assurance (NCQA), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), or similar organization; 3.1.3For Staff Model MCOs, evidence that the MCO satisfies the physical plant requirements of a hospital as specified by the Delaware Department of Health and Social Services; 3.1.4Copies of management, agency or administrative contracts; 3.1.5Equifax Reports on Officers/Directors; and/or NAIC biographical or other similar biographical forms, as directed by the Department; 3.1.6Proof of $50,000 bond for each officer, director, partner, or other individual who receives, collects or invests money; 3.1.7“Admittance Questionnaire for Certificate of Authority for Managed Care Organization,” Form No. H-2 (Exhibit B to this regulation); 3.1.8“Designation of official authorized to appoint and remove agents,” Form No. H-3 (Exhibit C to this regulation); 3.1.9“Designation of person to receive bulletins, regulations, etc.,” Form No. H-4 (Exhibit D to this regulation); 3.1.10“Designation of person to receive service of process,” Form No. H-5 (Exhibit E to this regulation); 3.1.11“Biographical Affidavit of Officers and Directors” (Exhibit F to this regulation); and 3.1.12“Power of Attorney Form” (Exhibit G to this regulation). 3.2Each application for a Certificate of Authority as a Managed Care Organization shall be accompanied by a $750 filing fee in accordance with 18 Del. C. §6409. 3.3Each application for a Certificate of Authority as a Managed Care Organization shall be accompanied by a deposit of $100,000 in accordance with 18 Del.C. §513(f). 3.4All of the items and information specified in the foregoing sections 3.1 through 3.3 must be submitted in order for the Department to review an application for a Certificate of Authority. 3.5Denial of Application for Certificate of Authority 3.5.1If, within 60 days after a complete application for a Certificate of Authority has been filed, the Department has not issued such certificate, the Department shall immediately notify the applicant, in writing, of the reasons why such certificate has not been issued, and the applicant shall be entitled to request a hearing on the application. 3.5.2The hearing shall be held within 60 days of the Department’s receipt of the applicant’s written request therefor. Proceedings in regard to such hearing shall be conducted in accordance with provisions for case decisions as set forth in the Administrative Procedures Act, Chapter 101 of Title 29, and in accordance with applicable rules and regulations of the Department. 4.0Capital Funds Required 4.1Each MCO that obtains a Certificate of Authority shall have and maintain unimpaired capital stock or unimpaired basic surplus of at least $300,000 and free surplus of at least $150,000 or the minimum capital and free surplus as may be required by legislative changes adopted by the General Assembly from time to time. These capital and surplus requirements are in addition to the deposit requirements of 18 Del.C. §513(f). 4.2Each MCO that obtains a Certificate of Authority shall demonstrate that it has provider contracts which require that the provider agrees in the event of non-payment by the MCO that the provider will not seek compensation or have any recourse against an enrollee, as described in section 7.0 of this regulation. In the event that the MCO has not entered into such agreements with all providers, the MCO must demonstrate to the Department's satisfaction that it has made a good faith effort to enter into these agreements. In lieu of these executed provider agreements, the Department, at its discretion, may allow the MCO to engage in the business of a managed care organization if the MCO establishes reserves equal to 25% of the total projected annual incurred claims or benefits payments attributable to the provider which or who has not agreed to enter into a provider agreement. 4.3Annually, at the time of filing the annual report on June 1, each MCO which has a current Certificate of Authority shall demonstrate that it is in compliance with the requirements of Sections 4.1 and 4.2 of this regulation. 5.0Reinsurance Requirement 5.1Each MCO shall secure insurance reinsurance protection to provide to the MCO in the event of catastrophic or unusual losses which would be in excess of the levels of loss which the MCO assumes in the basis of its calculation of premium charges. 6.0Special Requirement in the Event of Financial Impairment/Insolvency 6.1In the event of the financial impairment or insolvency of an MCO doing business in this State, each MCO doing business in this State shall permit a 60-day "open enrollment" period for existing enrollees of the impaired/insolvent MCO to enroll in a solvent MCO. 6.2Each such solvent licensed MCO shall be required to accept within the "open enrollment" period any enrollee who wishes to enroll at the rates or costs and benefits which are then in effect at the chosen MCO for the class or grouping represented by the enrollee. 6.3Each such solvent licensed MCO shall accept such enrollee without any waiting periods or pre-existing conditions exclusions and such acceptance both as to premium as well as delivery of service shall be retroactive to the date on which a court of competent jurisdiction has declared the predecessor MCO financially impaired. 7.0Required Contractual Provisions 7.1Every contract between an MCO and a participating provider shall contain the following language: 7.1.1“Provider agrees that in no event, including but not limited to nonpayment by the MCO or intermediary, insolvency of the MCO or intermediary, or breach of this agreement, shall the provider bill, charge, collect a deposit from, seek compensation, remuneration or reimbursement from, or have any recourse against an enrollee or a person (other than the MCO or intermediary) acting on behalf of the enrollee for services provided pursuant to this agreement. This agreement does not prohibit the provider from collecting coinsurance, deductibles or co-payments, as specifically provided in the evidence of coverage, or fees for uncovered services delivered on a fee-for-service basis to enrollees.” 7.1.2“In the event of an MCO or intermediary insolvency or other cessation of operations, covered services to enrollees will continue through the period for which a premium has been paid to the MCO on behalf of the enrollee or until the enrollee’s discharge from an inpatient facility, whichever time is greater. Covered benefits to enrollees confined in an inpatient facility on the date of insolvency or other cessation of operations will continue until their continued confinement in an inpatient facility is no longer medically necessary.” 7.2The contract provisions that satisfy the requirements of Section 7.1 above shall be construed in favor of the enrollee, shall survive the termination of the contract regardless of the reason for termination, including the insolvency of the MCO, and shall supersede any oral or written contrary agreement between a participating provider and an enrollee or the representative of an enrollee if the contrary agreement is inconsistent with the hold harmless and continuation of covered services provisions required by Section 7.1 above. 7.3A contract between an MCO and a participating provider shall not contain definitions or other provisions that conflict with the definitions or provisions contained in this regulation. 8.0Enrollee Rights and Responsibilities 8.1The MCO shall establish and implement written policies and procedures regarding the rights of enrollees and the implementation of these rights. 8.2The MCO shall disclose to each new enrollee, and any enrollee upon request, in a format and language understandable to a layperson, the following minimum information: 8.2.1Benefits covered and exclusions or limitations, including restrictions related to preexisting conditions; 8.2.2Out-of-pocket costs to the enrollee; 8.2.3Lists of participating providers; 8.2.4Policies on the use of primary care physicians, referrals, use of out of network providers, and out of area services; 8.2.5Policies governing the provision of emergency and urgent care; 8.2.6Written explanation of the internal and external review processes; 8.2.7For staff model MCOs, the location and hours of its inpatient and outpatient health services; 8.2.8A statement of enrollee’s rights that includes at least the right: 8.2.8.1To available and accessible services when medically necessary, including availability of care 24 hours a day, seven days a week for urgent or emergency conditions; 8.2.8.2 To be treated with courtesy and consideration, and with respect for the enrollee’s dignity and need for privacy; 8.2.8.3To be provided with information concerning the MCO’s policies and procedures regarding products, services, providers, grievance procedures and other information about the organization and the care provided; 8.2.8.4To choose a primary care provider within the limits of the covered benefits and plan network, including the right to refuse care of specific practitioners; 8.2.8.5To receive from the enrollee’s physician(s) or provider, in terms that the enrollee understands, an explanation of his complete medical condition, recommended treatment, risk(s) of the treatment, expected results and reasonable medical alternatives. If the enrollee is not capable of understanding the information, the explanation shall be provided to his next of kin or guardian and documented in the enrollee’s medical record; 8.2.8.6To formulate advance directives; 8.2.8.7To all the rights afforded by law or regulation as a patient in a licensed health care facility, including the right to refuse medication and treatment after possible consequences of this decision have been explained in language the enrollee understands; 8.2.8.8To prompt notification of termination or changes in benefits, services or provider network; 8.2.8.9To file a grievance with the MCO and to receive a response to the grievance within a reasonable period of time; and 8.2.8.10To file a petition for arbitration or appeal for review by an Independent Utilization Review Organization, as appropriate. 8.2.9A complete statement of responsibilities of enrollees. 8.3In the case of nonpayment by the MCO to a participating provider for a covered service in accordance with the enrollee’s health care contract, the provider may not bill the enrollee. This does not prohibit the provider from collecting coinsurance, deductibles or co-payments as determined by the MCO. This does not prohibit the provider and enrollee from agreeing to continue services solely at the expense of the enrollee, as long as the provider clearly informs the enrollee that the MCO will not cover these services. 9.0Provider Relations 9.1An MCO shall establish a mechanism by which participating providers will be notified on an ongoing basis of the specific covered health services for which the provider will be responsible, including any limitations or conditions on services. 9.2An MCO shall establish procedures for resolution of administrative, payment or other disputes between providers and the MCO. 9.3The MCO shall establish a policy governing termination of providers. The policy shall include at least: 9.3.1Written notification to each enrollee six weeks prior to the termination or withdrawal from the MCO’s provider network of an enrollee’s primary care physician except in cases where termination was due to unsafe health care practices; and 9.3.2Except in cases where termination was due to unsafe health care practices that compromise the health or safety of enrollees, assurance of continued coverage of services at the contract price by a terminated provider for up to 120 calendar days after notification of termination in cases where it is medically necessary for the enrollee to continue treatment with the terminated provider. In cases of the pregnancy of an enrollee, medical necessity shall be deemed to have been demonstrated and coverage shall continue to completion of postpartum care. 10.0Prohibited Practices 10.1An MCO shall not offer incentives to a participating provider to provide less than medically necessary services to an enrollee. 10.2An MCO shall not penalize a participating provider because the provider, in good faith, reports to State authorities any act or practice by the MCO that jeopardizes patient health or welfare. 10.3An MCO shall not engage in any other practices prohibited by applicable provisions of Title 18 of the Delaware Code and regulations promulgated thereunder. 11.0Quality Assurance and Operations 11.1Medical Director’s Duties. The medical director shall be responsible for the direction, provision and quality of health care services provided to enrollees, including but not limited to the following: 11.1.1Establishing policies and procedures covering all health care services provided to enrollees; 11.1.2Coordinating, supervising and overseeing the functioning of professional services; 11.1.3Providing clinical direction and leadership to the continuous quality improvement and utilization management programs; 11.1.4Providing clinical direction to physicians responsible for utilization management determinations; 11.1.5Establishing a committee responsible for delineating qualifications of participating providers and reviewing and verifying credentials of participating providers; 11.1.6Evaluating the medical aspects of provider contracts; and 11.1.7Overseeing the continuing in-service education of professional staff. 11.2Health Care Professional Credentialing 11.2.1General Responsibilities. An MCO shall: 11.2.1.1Establish written policies and procedures for credentialing verification of all health care professionals with whom the MCO contracts and apply these standards consistently; 11.2.1.2Verify the credentials of a health care professional before entering into a contract with that health care professional; 11.2.1.3Make available for review by the applying health care professional upon written request all application and credentialing verification policies and procedures; 11.2.1.4Retain all records and documents relating to a health care professional’s credentialing verification process for not less than four years; and 11.2.1.5Keep confidential all information obtained in the credentialing verification process, except as otherwise provided by law. 11.2.2Selection standards for participating providers shall be developed for primary care professionals and each health care professional discipline. The standards shall be used in determining the selection of health care professionals by the MCO, its intermediaries and any provider networks with which it contracts. Selection criteria shall not be established in a manner: 11.2.2.1That would allow an MCO to avoid high-risk populations by excluding providers because they are located in geographic areas that contain populations or providers presenting a risk of higher than average claims, losses or health services utilization; or 11.2.2.2That would exclude providers because they treat or specialize in treating populations presenting a risk of higher than average claims, losses or health services utilization. 11.2.3Nothing in these regulations shall be construed to require an MCO to select a provider as a participating provider solely because the provider meets the MCO’s credentialing verification standards, or to prevent the MCO from utilizing separate or additional criteria in selecting the health care professionals with whom it contracts. 11.2.4Verification Responsibilities. An MCO shall: 11.2.4.1Obtain primary verification of at least the following information about the applicant: 11.2.4.1.1current license, certification, or registration to render health care in Delaware and history of same; 11.2.4.1.2current level of professional liability coverage, if applicable; 11.2.4.1.3status of hospital privileges, if applicable; 11.2.4.1.4specialty board certification status, if applicable; and 11.2.4.1.5current Drug Enforcement Agency (DEA) registration certificate, if applicable. 11.2.4.2Obtain, subject to either primary or secondary verification: 11.2.4.2.1the health care professional’s record from the National Practitioner Data Bank; and 11.2.4.2.2the health care professional’s malpractice history. 11.2.4.3Not less than every three years obtain primary verification of a participating health care professional’s: 11.2.4.3.1current license or certification to render health care in Delaware; 11.2.4.3.2current level of professional liability coverage, if applicable; 11.2.4.3.3status of hospital privileges, if applicable; 11.2.4.3.4current DEA registration certificate, if applicable; and 11.2.4.3.5specialty board certification status, if applicable. 11.2.4.4Require all participating providers to notify the MCO of changes in the status of any of the items listed in this section 11.2.4 at any time and identify for participating providers the individual to whom they should report changes in the status of an item listed in this section 11.2.4. 11.2.5Health Care Professional’s Right to Review Credentialing Verification Information. An MCO shall provide a health care professional the opportunity to review and correct information submitted in support of that health care professional’s credentialing verification application. 11.3Provider Network Adequacy 11.3.1Primary, Specialty and Ancillary Providers 11.3.1.1The MCO shall maintain an adequate network of primary care providers, specialists, and other ancillary health care resources to serve enrollees at all times. 11.3.1.2If a plan has an insufficient number of providers that are geographically accessible and available within a reasonable period of time to provide covered health services to enrollees, the MCO shall cover non-network providers, and shall prohibit balance billing. 11.3.1.3The MCO shall allow referral to a non-network provider, upon the request of a network provider, when medically necessary covered health services are not available through network providers, or the network providers are not available within a reasonable period of time. The MCO shall make acceptable service arrangements with the provider and enrollee, and shall prohibit balance billing. 11.3.2Facility and Ancillary Health Care Services 11.3.2.1The MCO shall maintain contracts or other arrangements acceptable to the Department with institutional providers which have the capability to provide covered health services to enrollees and are geographically accessible. 11.3.2.2The MCO shall make acceptable service arrangements with the provider and enrollee, and shall prohibit balance billing, if the appropriate level of service is not geographically accessible. These services will not be limited to the State of Delaware. These services could include but are not limited to tertiary services, burn units and transplant services. 11.3.3Emergency and Urgent Care Services 11.3.3.1The MCO shall establish written policies and procedures governing the provision of emergency and urgent care which shall be distributed to each enrollee at the time of initial enrollment and after any revisions are made. These policies shall be easily understood by a layperson. 11.3.3.2When emergency care services are performed by non-network providers, the MCO shall make acceptable service arrangements with the provider and enrollee, and shall prohibit balance billing. In those cases where the MCO and the provider cannot agree upon the appropriate charge, the provider may petition the Department for arbitration. 11.3.3.3Enrollees shall have access to emergency care 24 hours per day, seven days per week. The MCO shall cover emergency care necessary to screen and stabilize an enrollee and shall not require prior authorization of such services if a prudent lay person acting reasonably would have believed that an emergency medical condition existed. 11.3.3.4Emergency and urgent care services shall include but are not limited to: 11.3.3.4.1medical and psychiatric care, which shall be available 24 hours a day, seven days a week; 11.3.3.4.2trauma services at any designated Level I or II trauma center as medically necessary. Such coverage shall continue at least until the enrollee is medically stable, no longer requires critical care, and can be safely transferred to another facility, in the judgment of the treating physician. If the MCO requests transfer to a hospital participating in the MCO network, the patient must be stabilized and the transfer effected in accordance with federal regulations at 42 CFR 489.20 and 42 CFR 489.24; 11.3.3.4.3out of area health care for urgent or emergency conditions where the enrollee cannot reasonably access in-network services; 11.3.3.4.4hospital services for emergency care; and 11.3.3.4.5upon arrival in a hospital, a medical screening examination, as required under federal law, as necessary to determine whether an emergency medical condition exists. 11.3.3.5When an enrollee has received emergency care from a non-network provider and is stabilized, the enrollee or the provider must request approval from the MCO for continued post-stabilization care by a non-network provider. The MCO is required to approve or disapprove coverage of post-stabilization care as requested by a treating physician or provider within the time appropriate to the circumstances relating to the delivery of services and the condition of the enrollee, but in no case to exceed one hour from the time of the request. 11.3.4The MCO shall submit evidence of network adequacy to the Department upon request. If the Department receives a complaint regarding an MCO’s network adequacy, the burden shall be on the MCO to prove network adequacy to the satisfaction of the Department. 11.4Utilization Management 11.4.1The MCO shall establish and implement a comprehensive utilization management program to monitor access to and appropriate utilization of health care and services. The program shall be under the direction of a designated physician and shall be based on a written plan that is reviewed at least annually. 11.4.2Utilization management determinations shall be based on written clinical criteria and protocols reviewed and approved by practicing physicians and other licensed health care providers within the network. These criteria and protocols shall be periodically reviewed and updated, and shall, with the exception of internal or proprietary quantitative thresholds for utilization management, be readily available, upon request, to affected providers and enrollees. 11.4.3All materials including internal or proprietary materials for utilization management shall be available to the Department upon request. 11.4.4Compensation to persons providing utilization review services for an MCO shall not contain incentives, direct or indirect, for these persons to make inappropriate review decisions. Compensation to any such persons may not be based, directly or indirectly, on the quantity or type of adverse determinations rendered. 11.4.5Utilization Management Staff Availability 11.4.5.1At a minimum, appropriately qualified staff shall be immediately available by telephone, during routine provider work hours, to render utilization management determinations for providers. 11.4.5.2The MCO shall provide enrollees with a toll free telephone number by which to contact customer service staff on at least a five day, 40 hours a week basis. 11.4.5.3The MCO shall supply providers with a toll free telephone number by which to contact utilization management staff on at least a five day, 40 hours a week basis. 11.4.5.4The MCO must have policies and procedures addressing response to inquiries concerning emergency or urgent care when a PCP or his authorized on call back up provider is unavailable. 11.4.6Utilization Management Determinations 11.4.6.1All determinations to authorize services shall be rendered by appropriately qualified staff. 11.4.6.2All determinations to deny or limit an admission, service, procedure or extension of stay shall be rendered by a physician. The physician shall be under the clinical direction of the medical director responsible for medical services provided to the MCO’s Delaware enrollees. Such determinations shall be made in accordance with clinical and medical criteria and standards and shall take into account the individualized needs of the enrollee for whom the service, admission, procedure or extension is requested. 11.4.6.3All determinations shall be made on a timely basis as required by the exigencies of the situation. 11.4.6.4An MCO may not retroactively deny reimbursement for a covered health service provided to an enrollee by a provider who relied upon the written or verbal authorization of the MCO or its agents prior to providing the service to the enrollee, except in cases where the MCO can show that there was material misrepresentation, fraud or the patient was found not to have coverage. 11.4.6.5An enrollee must receive written notice of all determinations to deny coverage or authorization for services required and the basis for the denial. 11.5Quality Assessment and Improvement 11.5.1Continuous Quality Improvement 11.5.1.1Under the direction of the Medical Director or his designated physician, the MCO shall have a system-wide continuous quality improvement program to monitor the quality and appropriateness of care and services provided to enrollees. This program shall be based on a written plan which is reviewed at least semi-annually and revised as necessary. 11.5.1.2The MCO shall assure that participating providers have the opportunity to participate in developing, implementing and evaluating the quality improvement system. 11.5.1.3The MCO shall provide enrollees the opportunity to comment on the quality improvement process. 11.5.1.4The MCO shall follow up on findings from the program to assure that effective corrective actions have been taken, including at least policy revisions, procedural changes and implementation of educational activities for enrollees and providers. 11.5.1.5The MCO shall make documentation regarding the quality improvement program available to the Department upon request. 11.5.2External Quality Audit 11.5.2.1Each MCO shall submit, as a part of its annual report due June 1, evidence of its most recent external quality audit that has been conducted or of acceptable accreditation status. 11.5.2.2The report of the external quality audit must describe in detail the MCO’s conformance to performance standards and the rules within this regulation. The report shall also describe in detail any corrective actions proposed and/or undertaken by the MCO. 11.5.2.3External quality audits must be completed no less frequently than once every three years. Such audit shall be performed by a nationally known accreditation organization or an independent quality review organization acceptable to the Department. 11.5.2.4In lieu of the external quality audit, the Department may accept evidence that an MCO has received and has maintained the appropriate accreditation from a nationally known accreditation organization or independent quality review organization. 11.5.3Reporting and Disclosure Requirements 11.5.3.1An MCO shall document and communicate information about its quality assessment program and its quality improvement program, and shall: 11.5.3.1.1include a summary of its quality assessment and quality improvement programs in marketing materials; 11.5.3.1.2include a description of its quality assessment and quality improvement programs and a statement of enrollee rights and responsibilities with respect to those programs in the materials or handbook provided to enrollees; and 11.5.3.1.3make available annually to participating providers and enrollees findings from its quality assessment and quality improvement programs and information about its progress in meeting internal goals and external standards, where available. The reports shall include a description of the methods used to assess each specific area and an explanation of how any assumptions affect the findings. 11.5.3.2An MCO shall submit to the Department such performance and outcome data as the Department may request. 12.0Recordkeeping and Reporting Requirements 12.1Medical Records Retention 12.1.1The MCO must maintain or provide for the maintenance of a medical records system which meets the accepted standards of the health care industry and State and federal regulations. 12.1.1.1The MCO shall provide sufficient space and equipment for the processing and the safe storage of records. 12.1.1.2Medical records shall be protected from loss, damage and unauthorized use. 12.1.2Retention and Destruction 12.1.2.1With the exception of medical records of minors (individuals under the age of 18 years), medical records shall be preserved as original records, on microfilm or electronically stored for no less than five years after the most recent patient care usage, after which time records may be destroyed at the discretion of the MCO. 12.1.2.2Medical records of minors shall be preserved for the period of minority plus five years (i.e., 23 years) or as otherwise required by State law. 12.1.2.3An MCO shall establish procedures for notification to patients whose records are to be destroyed prior to the destruction of such records. 12.1.3The Department shall have access to medical records for purposes of monitoring and review of MCO practices. 12.2Reporting Requirements and Statistics 12.2.1Annual reports. In addition to the information required to be included in an MCO’s annual report as specified in 18 Del.C. §6406 or elsewhere in this regulation, an MCO shall submit the following information to the Department on an annual basis: 12.2.1.1A statistical summary evaluating the network adequacy and accessibility to the enrolled population; 12.2.1.2Annual appeal report of all grievances, petitions for arbitration and appeals under the Independent Health Care Appeals Program as required under Department Regulation 1301. 12.2.1.3Evidence of compliance with the capital funds requirements of section 4.0 of this regulation. 12.2.2An MCO shall submit the following information to the Department whenever there is a change: 12.2.2.1Substantial changes in organization, bylaws, or governing board 12.2.2.2Full name of the Chief Executive Officer 12.2.2.3Full name of the Medical Director 12.2.2.4Substantial changes in marketing materials, grievance procedures or the utilization management program 12.2.2.5Any significant amendment to or revision relating to the text or subtext of an approved provider contract shall be submitted to and approved by the Department prior to the execution of an amended or revised contract with the providers of an MCO. 13.0Compliance with Regulation 13.1The MCO is responsible for meeting each requirement of this regulation. If the MCO chooses to utilize contract support or to contract functions under this regulation, the MCO retains responsibility for ensuring that the requirements of this regulation are met. 13.2The Department may require a corrective action plan from an MCO when the Department determines that the MCO is not in compliance with applicable provisions of Title 18 of the Delaware Code or regulations promulgated thereunder. 14.0Separability Provisions 14.1If any provision of this regulation shall be held invalid, the remainder of the regulation shall not be affected thereby. DEPARTMENT OF EDUCATIONOFFICE OF THE SECRETARYStatutory Authority: 14 Delaware Code, Section 122(d) (14 Del.C. §122(d)) 14 DE Admin. Code 502 Education Impact Analysis Pursuant To 14 Del.C. Section 122(d) 502 Alignment of Local School District Curricula to the State Content StandardsA.Type of Regulatory Action Required Amendment to Existing Regulation B.Synopsis of Subject Matter of the Regulation The Secretary of Education intends to amend 14 DE Admin. Code 502 Section 6.0 in order to clarify the descriptions of the categories of evidence of alignment to the state content standards that are required for submission to the Department of Education and to change the grade cluster configuration. The changes have been made as a result of a pilot study involving unofficial review of curriculum evidence from a small number of districts. Persons wishing to present their views regarding this matter may do so in writing by the close of business on Monday March 5, 2007 to Carol O'Neill Mayhew, Education Associate, Regulation Review, Department of Education, at 401 Federal Street, Suite 2, Dover, DE 19901. A copy of this regulation is available from the above address or may be viewed at the Department of Education business office. C.Impact Criteria 1.Will the amended regulation help improve student achievement as measured against state achievement standards? The purpose of the alignment project is to insure that the curriculum in all of the school districts is aligned with the state content standards which should assist in improving student achievement. 2.Will the amended regulation help ensure that all students receive an equitable education? The alignment project should help to ensure that all students receive an equitable education. 3.Will the amended regulation help to ensure that all students' health and safety are adequately protected? The amended regulation addresses alignment of curriculum with the state content standards not health and safety issues. 4.Will the amended regulation help to ensure that all students' legal rights are respected? The amended regulation addresses alignment of curriculum with the state content standards not students legal rights. 5.Will the amended regulation preserve the necessary authority and flexibility of decision making at the local board and school level? The amended regulation will preserve the necessary authority and flexibility of decision making at the local board and school level. 6.Will the amended regulation place unnecessary reporting or administrative requirements or mandates upon decision makers at the local board and school levels? The amended regulation does include reporting requirements concerning curriculum alignment to the state content standards. 7.Will the decision making authority and accountability for addressing the subject to be regulated be placed in the same entity? The decision making authority and accountability for addressing the subject to be regulated will rem